# K120062: DRX-Revolution Mobile X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Apr 13, 2012 after 95 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041763 (2004). 1 ancestor in all.
41 later devices descend from it; 5 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041763: Shimadzu Mobile X-Ray System Mux-100D Series, Shimadzu Corp. (2004) Summary page 1.

## Most influential descendants
- K123526: Clearread +Confirm (2012), 25 descendants of its own
- K162278: Digital Diagnostic Mobile X-ray System (2016), 23 descendants of its own
- K171119: GM85 (2017), 22 descendants of its own
- K173828: GU60A & GU60A-65 (2018), 19 descendants of its own
- K180543: GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 (2018), 18 descendants of its own

## Recalls of this device
- May 25, 2017 · Class II · Z-2651-2017: Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.
- Jan 12, 2017 · Class II · Z-1138-2017: The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.
- Nov 25, 2014 · Class II · Z-0800-2015: While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System in
- Aug 29, 2013 · Class II · Z-0179-2014: Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable System
- Jul 26, 2013 · Class II · Z-0090-2014: During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is
- Jun 19, 2013 · Class II · Z-0132-2014: Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.
- Jun 6, 2013 · Class II · Z-0126-2014: Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch.

## Indications for use
The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

Source page: https://510kreport.com/device/K120062
Methodology: https://510kreport.com/methodology